510(k) K142147
K142147 is an FDA 510(k) premarket notification submitted by Auxogyn, Inc. for the device "EEVA SYSTEM". The FDA issued a decision of Substantially Equivalent on November 24, 2014. The device falls under product code PBH (Embryo Image Assessment System, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6195. Auxogyn, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 24, 2014
- Date Received
- August 5, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Embryo Image Assessment System, Assisted Reproduction
- Device Class
- Class II
- Regulation Number
- 884.6195
- Review Panel
- OB
- Submission Type
The device will obtain and analyze light microscopy images of developing embryos. This device provides information to aid in the selection of embryo(s) for transfer when there are multiple embryos deemed suitable for transfer or freezing .